JP2014521393A - Cleaning device and catheter kit including cleaning device - Google Patents

Abstract

  The present invention relates to an irrigation device (8) that can be used in the insertion of a bladder catheter. The cleaning device (8) comprises a flexible container (9) defining a compartment (12) adapted to be filled with a liquid and a connector (10) attached to the container (9). The connector (10) is adapted to be connected to a catheter, and the connector (10) is provided with an opening (11). The flexible container (9) is interconnected with the connector (10) via the lumen (13), allowing liquid to pass from the flexible container (9) through the connector (10) in the lumen (13), It can take out from an opening part (11). The flexible container further includes a detent valve (14) disposed in the lumen (13). The invention also relates to a kit comprising such a cleaning device (8).

Description

The present invention relates to an irrigation device for inserting a catheter into the bladder and a kit comprising the irrigation device.

BACKGROUND A catheter may have to be used to drain and collect urine from the bladder or to inject fluid used to treat or diagnose a bladder condition. A catheter is a flexible tube that passes through the urethra and enters the bladder. In conventional catheters, the tube has two separate passages or lumens extending along its length. One lumen is open at both ends, allowing urine to drain into the collection bag. The other lumen has a valve on the outer end and connects to the balloon at the tip. The balloon is inflated when positioned inside the bladder to prevent it from sliding out.

  Introducing a catheter to insert the catheter into the bladder can be difficult and can be a painful procedure, especially for male patients. The procedure often causes tissue damage or bleeding, can lead to serious infections, can cause convulsions and spasms, and is more difficult to introduce a catheter.

  Today, the usual method for inserting a catheter into the bladder, obtained from the “Healthcare Handbook” in Vaestra Goetallands in a hospital, is performed as follows.

  1. A sterile gel / anesthetic gel is applied to the tip of the catheter, introduced into the urethra and allowed to run for 5 minutes (20 g of gel is the preferred dose for male patients).

2. Lift the penis perpendicular to the patient's body.
3. Place the tube against the urethral opening and gently squeeze out half of the gel. Resistance is felt when the gel reaches the sphincter.

4). Wait with pressure against the end of the penis or use penile forceps.
5. Approximately 1 minute later, when the sphincter is relaxed, the remaining amount of gel is introduced. In this way, the entire urethra is filled with gel.

  6). Carefully feed the catheter directly from the packaging into the urethra. Alternatively, remove the catheter from the package, place the catheter in the pus basin, and introduce the catheter using sterile or clean tweezers or with gloves. Do not push in.

7). Retract the foreskin and hold the penis extended.
8). Introduce the full length of the catheter.

9. Wait for the urine to flow naturally. Let urine flow into a clean pus basin.
10. Fill the catheter balloon with the amount of fluid recommended by the manufacturer, usually 10 ml of sterile water.

  The advantage of the above procedure is that it is a well-validated method. But there are drawbacks. In other words, convulsions, pain, bleeding and tissue damage can occur, and as a result, the risk of infection increases when a catheter is inserted into a patient with prostatic hypertrophy, neurological disease, or the like. Therefore, there is a need for an improved procedure for introducing a catheter.

  The present invention aims to solve the problems of conventional methods for introducing catheters.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide an improved procedure for catheter insertion.

The above object is achieved by the present invention according to the independent claims.
Preferred embodiments are set forth in the dependent claims.

  Accordingly, in a first aspect of the invention, an irrigation device is provided that can be used in bladder catheterization. The cleaning device comprises a flexible container defining a compartment adapted to be filled with a liquid and a connector attached to the container, the connector adapted to be connected to the catheter and connected to the connector. Is provided with an opening. The flexible container is interconnected with the connector via a lumen, allowing liquid to pass from the flexible container through the connector in the lumen and out of the opening. The cleaning device further includes a detent valve disposed in the lumen.

  In order to eliminate or at least reduce the drawbacks of the prior art methods, the inventor has devised a new method using a new creative device.

  The advantage of the new method over the prior art method is that it does not cause convulsions when the catheter is inserted with liquid from the cleaning device. Also, this gentle method does not cause tissue damage or bleeding. As with normal catheters, it is not necessary to fill the urethra with anesthetic lubricant to reduce urethral lumen space.

  Patients with stenosis in the urethra or enlarged prostate are a group that can cause technical problems when introducing a catheter. The urethral lumen is smaller due to stenosis or enlargement of the prostate, thus making it difficult to penetrate the catheter. In the irrigation method described herein, the catheter goes very easily with any liquid over any stenosis.

  The method provides a gentle and painless introduction of the catheter with minimal risk of tissue damage or bleeding that can lead to serious infection.

  The method is particularly suitable for patients with neurological disorders. They are more prone to convulsions / spasticity, which is difficult when introducing a catheter. Because the procedure is rapid and does not irritate the tissue, convulsions are not induced using this method.

  There is no need to reposition the penis to fill the urethra with anesthetic gel. The act itself can cause convulsions. The need for specialists (urologists) to perform catheter insertion is reduced.

  Furthermore, the method saves time because it is not necessary to wait for the anesthetic to take effect. There is no need to use expensive dedicated catheters. In particular, the method is painless and friendly to both the patient and the user.

1 is a schematic view of a catheter according to the prior art. 1 is a top view of an irrigation device for inserting a catheter into the bladder according to the present invention. FIG. 1 is a side view of an irrigation device for inserting a catheter into a bladder according to the present invention. FIG. 1 is a front view of an irrigation device for inserting a catheter into a bladder according to the present invention. FIG. It is detailed sectional drawing of the washing | cleaning apparatus and detent valve which concern on one Embodiment of this invention.

Detailed Description of the Preferred Embodiments of the Invention In order to better understand the circumstances in which an irrigation device will be used, a schematic diagram of a conventional catheter 1 for inserting a catheter into the bladder is shown in FIG. The catheter 1 includes a flexible tube 2 adapted to pass through the urethra and into the bladder. Tube 2 includes two separate passages or lumens extending in its longitudinal direction. The first lumen is open at both ends 3 ′, 3 ″, allowing urine to flow out, the second lumen has a valve 4 on the outer end 5, and a balloon 6 at the tip 7. In fluid communication.

  FIG. 2 shows an embodiment of an irrigation device 8 that can be used in catheterization of the bladder. The cleaning device 8 includes a flexible container 9 that defines a compartment 12 (not shown in FIG. 2) adapted to be filled with a liquid, and a connector 10 provided with an opening 11. Connector 10 is adapted to be connected to a catheter (not shown). The flexible container 9 is interconnected with the connector 10 by a tube 15 that exhibits an inner lumen 13 (see FIG. 5), and liquid can pass through the lumen 13 from the flexible container 9 to the opening 11. A detent valve 14 is disposed in the lumen 13.

  In use, a cleaning device 8 is connected to the drainage outlet 3 'of the catheter for inserting the catheter into the bladder. See FIG. During insertion of the catheter, the operator applies pressure to the flexible container 9 and liquid flows out through the tube 15 into the compartment 12 and out of the opening 11 in the connector 10 and into the catheter. The liquid then passes through the catheter lumen to the opening 3 "at the catheter tip. During insertion of the catheter, the liquid flowing through the catheter from the cleaning device 8 acts as a lubricant. The urethra before starting the procedure. May be moistened with liquid and then the catheter may be inserted, preferably during the insertion, the operator pushes the flexible container 9 2-3 times.

  It is preferred to fill compartment 12 with water or saline. The compartment 12 may be prefilled or connected to a liquid source by tubing (not shown). Preferably, compartment 12 contains about 100 ml of liquid. In one embodiment, compartment 9 contains 100 ml NaCl 9 mg / ml, or alternatively NaCl 9 mg / ml supplemented with 10 mg / ml xylocaine for anesthesia purposes. The flexible container 9 is further provided with a valve (not shown) so that the flexible container 9 can be expanded again to allow air to pass through the compartment 12 and facilitate the compression of the flexible container 9. Also good.

  In one embodiment, the connector 10 and the flexible container 9 are connected to each other by a tube 15 as illustrated in FIG. The lumen 13 thus extends along a tube 15 that extends between the connector 10 and the flexible container 9. The length L of the tube 15 is less than 50 mm, preferably 35 mm. However, as a structural modification, the connector 10 may be directly attached to the flexible container 9.

The diameter of the lumen can be approximately 10 mm. The diameter of the opening 11 can be approximately 6 mm.
FIG. 4 shows the front of the cleaning device 8 according to the present invention. As shown, the flexible container 9 is essentially box-shaped. That is, the flexible container 9 may have a rectangular cross section. A box shape is advantageous because the container 9 is easy to grasp. However, the flexible container 9 may have a spherical shape or other similar shape.

  FIG. 5 illustrates that the flexible container 9 includes an outlet port 16 connected to the lumen 13 and that the detent valve 14 is disposed adjacent to the outlet port 16. Alternatively, the detent valve 14 may be positioned closer to or adjacent to the opening 11 of the connector 10.

  The connector 10 may include a removable tip portion (not shown) adapted to seal the cleaning device 8. This is particularly advantageous if it has a prefilled compartment 12.

  2 to 5, the connector 10 is a male connector. However, the connector 10 can be a female connector or any other suitable connector adapted to be connected to a catheter.

  As illustrated in FIG. 5, the detent valve 14 is a detent flap valve. As a structural variation, the detent valve 14 is any other suitable detent valve, such as a ball check valve or a circular rubber membrane centered with a hole or opening having a flap. There may be. When pressure is applied to the outside of the flexible container 9, the flap will be opened by the liquid, and when the pressure is subsequently removed, the flap will fall so that the detent valve is closed. Alternatively, two openings including flaps may be provided in the membrane.

  The flexible container 9 is preferably made of polyethylene or any other soft material having similar flexible or elastic material properties.

  Since the catheter is manufactured according to universal standards and in the illustrated embodiment is a male type having a conical segment that is tapered to provide a friction fit in the catheter connection, the connector 10 of the cleaning device 8 is Adapted to fit all urinary catheters.

  Other possible types of connectors would be Luer-Lok® connectors, plug-in fittings, and threaded joints, for example.

  When pressure is applied to the flexible container 9, the detent valve 14 is opened. The liquid can then pass through the lumen 13 from the compartment 12 to the opening 11 and out of the opening 11.

  There are several alternative fields used for the cleaning device 8. For example, when flushing the urinary catheter after urine retention, flushing the bladder, or inserting the catheter into an animal using the same method as a human, the flushing device 8 may be used as it is or in a modified form.

  In another aspect, the invention provides a new method for urinary catheterization performed as follows.

1. Wash hands with soap and warm water.
2. The cleaning device 8 is attached to the catheter.

  3. Carefully rinse the catheter with fluid while leaving the fluid in its protective wrap to wet the outside of the catheter.

4). The penis must be on a flat surface.
5. The urethra is moistened with a few drops of liquid from the cleaning device 8 through the catheter.

6). The catheter is inserted into the urethra while holding the penis and catheter to introduce fluid.
7). The catheter is then inserted about 5 cm further. Do not push in.

8). Rinse the catheter and continue to pump liquid until fully inserted.
9. Remove the cleaning device 8 and wait for the urine to flow naturally. Let urine flow into a clean pus basin.

10. The catheter balloon must be filled according to the manufacturer's instructions.
Due to the rinsing method used with the cleaning device 8, a special catheter or skilled specialist is rarely needed.

  In yet another aspect of the invention, a kit including at least a catheter and a new cleaning device 8 is provided, and the kit parts are packaged in a sterile enclosure. The kit further includes an insertion tray / container, sterile packaging, two moisture proof drapes, a perforated absorbent pad, a powder-free glove, a syringe prefilled with 10 cc of sterile water for a cuff catheter balloon, a rayon ball 5, a compress 10 X10 cm2, and can include disposable tweezers.

  The cleaning device 8 is preferably pre-filled with sterile physiological salts, and the kit parts are packaged in a sterile housing, preferably a plastic bag.

  The present invention is not limited to the above preferred embodiments. Various alternatives, modifications and equivalents may be used. Accordingly, the above embodiments should not be taken as limiting the scope of the invention. The scope of the invention is defined by the appended claims.

Claims (10)

An irrigation device (8) usable in insertion of a bladder catheter,
A flexible container (9) defining a compartment (12) adapted to be filled with a liquid;
A connector (10) attached to the container (9), the connector (10) being adapted to be connected to a catheter, the connector (10) being provided with an opening (11) A flexible container (9) is interconnected with the connector (10) via a lumen (13) and allows liquid to pass from the flexible container (9) to the connector (10) in the lumen (13). A cleaning device (8), further comprising a detent valve (14) that can be removed from the opening (11) and disposed in the lumen (13).   The cleaning device according to claim 1, wherein the connector (10) and the flexible container (9) are connected to each other via a tube (15).   3. The cleaning device according to claim 2, wherein the length L of the tube (15) is less than 50 mm, preferably 35 mm.   The cleaning device according to claim 1, wherein the connector (10) is directly attached to the flexible container (9).   The flexible container (9) includes an outlet port (16) in fluid communication with the lumen (13), and the detent valve (14) is disposed adjacent to the outlet port (16). The cleaning apparatus according to any one of claims 1 to 4.   The cleaning device according to any one of claims 1 to 5, wherein the connector (10) is a male connector.   The cleaning device according to any one of claims 1 to 6, wherein the detent valve (14) is a detent flap valve.   The cleaning device according to any one of claims 1 to 6, wherein the detent valve (14) is a ball check valve.   A kit comprising at least a catheter and the cleaning device according to claim 1, wherein the kit parts are packaged in a sterile housing.   The kit according to claim 9, wherein the cleaning device (8) is filled with a sterile cleaning solution.

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